This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
49
3 intravitreal injections of THR-317 4mg approximately 1 month apart
3 intravitreal injections of THR-317 8mg approximately 1 month apart
Unnamed facility
Brno, Czechia
Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Prague, Czechia
Incidence of acute (up to the 7-day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject
Time frame: up to the 7-day follow-up visit after each injection
Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject
Time frame: up to the 30-day follow-up visit after each injection
Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150
Time frame: From day 0 to day 150
Proportion of subjects withdrawn from repeat injection and reason for withdrawal
Time frame: At day 30 and at day 60
Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit
Time frame: Up to day 150
Proportion of subjects with an acute loss (up to the 7-day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after each injection
Time frame: Up to 7-day follow-up visit after each injection
Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit
Time frame: Up to day 150
Mean change from baseline in BCVA, by study visit
Time frame: Up to day 150
Mean change from baseline in CST, by study visit, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Budapest, Hungary
Unnamed facility
Budapest, Hungary
Unnamed facility
Debrecen, Hungary
Unnamed facility
Pécs, Hungary
Unnamed facility
Szeged, Hungary
Unnamed facility
Bratislava, Slovakia
...and 3 more locations
Time frame: Up to day 150